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GaleMed Humi.AIDE Humidifier - HSA Registration DE0507257

Access comprehensive regulatory information for GaleMed Humi.AIDE Humidifier in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507257 and owned by GaleMed Corporation. The device was registered on September 13, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0507257
GaleMed Humi.AIDE Humidifier
HSA Registration Number: DE0507257
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Product Description

Humi.AIDE™ 5D Humidifier is intended to assist patient breathing for mitigation of breathing difficulties due to the lack of humidification. This device is indicated for patients requiring mechanical ventilation and other humidity therapies. The additional temperature probe is used to check temperature at the patient side. Humi.AIDE™ 5D Humidifier is intended for use on adult and pediatric patients in home care environment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507257
Registration Date
September 13, 2022
Retention Due Date
September 12, 2025
Product Owner
Short Name
GaleMed Corporation
Address
87 Li-gong 2nd Road,, Wu-Jia, I-Lan 268, TAIWAN
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-23, SINGAPORE 138565
Model Information
Model Name(s)
Humidification Chamber, Adult EVA Hose, 22F, 180cm EVA SB Hose, 22F, 180cm Filter, 22F/15M, 22M/15F Airsoft Mask, #0 Airsoft Mask, #1 Airsoft Mask, #2 Airsoft Mask, #3 Airsoft Mask, #4 Airsoft Mask, #5 Airsoft Mask, #0 w/Valve Airsoft Mask, #1 w/Valve Airsoft Mask, #2 w/Valve Airsoft Mask, #3 w/Valve Airsoft Mask, #4 w/Valve Airsoft Mask, #5 w/Valve Airsoft Mask, #6 w/Valve CPAP Silent Vent, Swivel CPAP Exhale Vent, 22M, 22M EVA Circuit, Adult, 150cm EVA Circuit, Adult, 180cm EVA Circuit, Adult, 60cmx4 w/2WT EVA Circuit, Child, 60cmx4 w/2WT EVA Circuit, Infant, 60cmx4 w/2WT Silicone Circuit, Adult, 120cm Silicone Circuit, Child, 120cm Single Limb Circuit, Adult, 150cm EVA Single Limb Circuit, 120cm L Connector, 22/15mm 15M Connector, 22M, 22/19mm, PP Cap, 22F, Green Filter, 22F/15M, 22M/15mm Durable Chamber, Adult H5D Humidifier, 240V
Model Identifier(s)
3424 38002 38051 39013 5301 5302 5303 5304 5305 5306 5311 5312 5313 5314 5315 5316 5337 54031 54032 6573 66636 6702 6703 6704 6733 6737 6790 6791 72211 74056 78011 7FAD12 HA02 HD52